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Pharmacovigilance Coordinator (Japanese Skills Required) at PSI CRO | HealthRoleIQ

Opportunity

Pharmacovigilance Coordinator (Japanese Skills Required)

PSI CRO·Taipei, Taiwan

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About the role

Permanent, full-time, office-based Pharmacovigilance Coordinator role in Taipei supporting global pharmacovigilance and in-country clinical teams. Responsibilities include processing and reporting safety information, safety-report data entry and quality control, query distribution, tracker and documentation maintenance, and literature searching and article triage in a Japanese scientific database. Full working proficiency in English and Japanese is required.

Key requirements

• College or University Degree (Biology, Bioscience, or Pharmacy is preferred)
• At least 1 year of relevant experience
• Required skills: Clinical research experience in a Clinical Trial Coordinator or similar clinical operational role, Pharmacovigilance Coordinator, Regulatory Specialist, Data Management Specialist or similar, Administrative work, Full working proficiency in English and Japanese, Organizational and planning skills, Detail orientation, Multitasking in a fast-paced environment, Communication and collaboration skills, Proficiency in Microsoft Word, Excel and PowerPoint
• Required languages: English, Japanese

Opportunity details

• Workplace: On Site
• Employment: Permanent
• Posted: Jul 31, 2026
• Original advert language: English

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Job title: Pharmacovigilance Coordinator (Japanese Skills Required)

Location: Taipei, Taiwan

Employment type: Full-time

Company Description

PSI is a leading Contract Research Organization with more than 30 years of experience in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

We are looking for a knowledgeable and proactive Pharmacovigilance Coordinator to join our enthusiastic and vibrant team.

In this role, you will provide day-to-day support to the company’s global Pharmacovigilance Department and In-country Clinical Caretaker (ICCC) in clinical trials with the corresponding services. You will process and report safety information (including electronic reporting) throughout the course of the clinical trials. You will help to enhance patient care and safety in relation to the use of novel pharmaceuticals and investigational devices, collect relevant and reliable medical scientific information.

Permanent / Full-time / Office-based

The scope of responsibilities will include:

Serve as a contact point for Safety Desk and clinical project teams ensuring appropriate receipt, timely distribution, documentation, and filing of safety reports such as Serious Adverse Events (SAEs) and other Reportable Adverse Events (RAEs) reports.
Data entry of safety reports into the safety database
Non-medical review/triage of incoming safety reports
Quality control of data entered in the safety database
Safety queries distribution to sites/ investigators
Maintenance and timely update of the company’s project-specific SAEs distribution lists
Review and timely update of project-specific SAEs trackers maintained by PSI project teams
A literature search conduction in a dedicated Japanese scientific database and article triage.
Maintain pharmacovigilance documentation and associated records, ensuring all relevant information remains up to date and appropriately documented.

Qualifications

College or University Degree (Biology, Bioscience, or Pharmacy is preferred)
Full working proficiency in English and Japanese
At least 1-year prior experience in Clinical Research as a Clinical Trial Coordinator or similar clinical operational role, Pharmacovigilance Coordinator, Regulatory specialist, Data Management Specialist or the like will be a plus
Administrative work experience
Experience with safety databases and E2B reporting to regulatory authority in Japan (PMDA) and other regulators is a plus
Organizational and planning skills
Detail-oriented, able to multi-task and work in a fast-paced environment
Communication and collaboration skills
Proficiency in standard MS Office applications (Word, Excel and PowerPoint)

Additional Information

Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.